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Bladder EpiCheck European Haematuria Study
Sponsor: Nucleix Ltd.
Summary
The goal of this observational study is to further validate the sensitivity and specificity of Bladder EpiCheck in primary detection of urothelial carcinoma in participants aged 45 years or older presenting with haematuria, compared to cystoscopy and pathology, if performed. Participants will provide a voided urine sample, and data from standard of care haematuria work-up will be collected.
Official title: Evaluation of the Efficacy of Bladder EpiCheck® for the Primary Detection of Urothelial Carcinoma in Subjects Presenting With Haematuria
Key Details
Gender
All
Age Range
45 Years - Any
Study Type
OBSERVATIONAL
Enrollment
800
Start Date
2025-06-20
Completion Date
2026-12
Last Updated
2026-01-22
Healthy Volunteers
No
Conditions
Interventions
Bladder EpiCheck
The participant will provide a voided urine sample, which will be tested using the Bladder EpiCheck test. The clinical care team and the participant will not be informed of the result, and the standard of care will not change.
Locations (5)
NHS Fife
Dunfermline, Fife, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
NHS Lothian
Edinburgh, United Kingdom
Guy's and St Thomas
London, United Kingdom
Frimley
Surrey Quays, United Kingdom